Biological and chemical sample containers are commonly used in the medical, chemical, bioscience and drug research and testing industries. These containers are typically made of plastic, glass, or a similar non-reactive material and cover a range of sizes and types. However, smaller vials such as, 0.5 mL, 1 mL, 1.5 mL, 1.8 mL, and the like, are widely used in the medical, chemical, bioscience and drug research and testing industries. In these industries, unique specimen samples (for example, blood or urine in the drug testing industry) are maintained in individual vials. The individual vials are often stored within a container such as a box that typically holds up to 100 vials per box. Laboratories and research facilities are two examples where the mission requires storage of specimen samples that number into the tens of thousands or hundreds of thousands in incubators, refrigerators, freezers, cryogens, and similar storage devices with increasing numbers of samples projected for collection, use and storage. In aggregate, these samples number into the millions. Therefore, given the number of samples that are stored it is imperative that each specimen sample is reliably identified and tracked in order to maintain the integrity of the research and testing, and to meet applicable reporting requirements.
Some prior specimen identification and tracking systems have including printed (written or handwritten) labels that require visual inspection, or a unique bar code along the side of the container that is typically located and scanned using a hand held optical scanner. The printed label systems require users to remove the trays from storage and remove the specimen vials from the tray in order to identify and track the specimen. The bar code labeling systems utilize a light beam emitted from the scanner to “read” the bar code label. Because the relationship of the single-use test device or biological or chemical sample container is by nature transitory and such items are either discarded following use or cleansed by some process, prior systems did not provide a mechanism for positive tracking of the sample or test object other than by barcode or handwritten labels. Handwritten, adhesive label and bar code technology requires positive line-of-sight and may be adversely affected by the contents of the sample, reagents and/or by physical handling of the test device or specimen container which may degrade the label such that it cannot be read by human eye or an optical reader. Bar code technology also requires sample containers to be removed from storage and handled individually, resulting in lengthy inventory processes that create a significant potential for loss or damage to the container and/or specimens because of their removal from the storage device.
Securely and efficiently protecting samples against tampering and contamination remains a critical concern. The vast majority of the existing samples are stored insecurely in a manner prone to tampering and contamination—often in vials having only a flip top, screw top, etc. that can be easily breached by unauthorized personnel. For example, a critical and urgent need exists to maintain a one-hundred percent inventory and accountability of all Biological and Select Agent and Toxin (BSAT) samples in the Department of Defense (DoD) Inventory. In addition, mechanisms must be put in place to monitor and notify of tampering or unauthorized access to such samples. BSAT samples must be secured in a manner appropriate to guard against misuse, theft, loss or accidental release. These inventory and security measures must be implemented in a coordinated manner that balances security and efficiency with access to scientists for the legitimate use of BSAT. The same need applies to numerous biological science laboratories in hospitals, blood storage facilities, fertility clinics, etc., i.e., anywhere inventory and accountability of valued or sensitive items are required at a moment's notice.
Increasing regulatory requirements by human and animal ethical use policies, as well as, state agency imposed requirements mandate accurate and efficient accountability of all specimens, prospective and retrospective. The increased requirements in addition to the mounting volumes of samples requiring storage demands a significant amount of additional administrative work to efficiently, securely and accurately inventory and account for biological samples. Currently, most laboratory personnel simply write a coded sequence number on the sample container directly or use an adhesive label to identify the contents. Limited by line-of-sight, the primary strategy to account for a sample is to physically remove it from its current storage condition such as in an incubator at approximately 37 C or a freezer, count the vials one-by-one, affirming that the label indicates a material exists in the container. Multiple permutations on line-of-sight strategies to streamline the inventory process are used. However, additional limitations create significant inefficiencies. But these inefficiencies can be overcome by use of the present invention.